Compositions and methods for promoting weight loss and increasing energy

ABSTRACT

The present invention relates to compositions comprising plants and extracts of plants with chlorogenic acids and antioxidants and/or caffeine; methods for preparing the same; and methods to promote weight loss through the administration of compositions containing these plants and plant extracts in specific proportions.

FIELD OF THE INVENTION

The present invention relates to novel methods and compositionscomprising chlorogenic acids for promoting weight loss, for thetreatment of obesity, managing weight gain, or maintenance of normalbody weight and for increasing energy of an individual participating ina weight loss regimen.

BACKGROUND OF THE INVENTION

Obesity is one of the most common medical disorders and affects about30-40% of the population of the United States, 10% of which may besevere and morbid. Complications of obesity include insulin resistance,diabetes mellitus (and its complications, including oxidative stress),hypertension, cardiovascular disease, hyperlipidemia, sleep apnea,cancer, pulmonary hypertension, cholecystitis, and osteoarthritis aremajor reasons for medical intervention. The mortality from obesity isestimated at 300,000 to 400,000 per annum in the United States. Theexact etiology of obesity is unknown but occurs when energy intakeexceeds energy expenditure.

One main contributing factor in obesity is overeating, which results inan excess of energy being consumed in relation to the amount of energyexpended by an individual. The excess energy is then stored largely asfat. An individual's body weight is essentially governed by the neteffect of energy consumed versus energy expended. Daily energyexpenditure consists of three components: basal metabolic rate, adaptivethermogenesis and physical activity. All of the aforementionedcomponents must be in a balance of energy expenditure in an individualwith energy or food intake so that an individual does not gain nor losebody weight. Therefore, for that person to lose body weight from areduction in adipose tissue, more energy must be expended by theindividual than taken into the body.

Losing weight and keeping it off is very difficult for most individuals.Weight gain results when an individual's caloric intake exceeds thenumber of calories expended as energy. In attempting to lose weight, anindividual may utilize a regimen of caloric deficit (i.e. decreasingcaloric intake so that calories expended as energy exceed caloricintake). Generally, the result is an adaptive response of a loweredbasal (resting) metabolic rate. Caloric deficit can also cause a loss ofskeletal muscle. Thus, weight loss or reducing caloric intake results ina lowering of resting energy expenditure and loss of lean body mass.This makes it harder to keep the weight off once the individual hasattained his desired weight goal.

When the body encounters an energy deficit in the course ofweight-reducing diets, it tends to save energy by reducingthermogenesis. This factor contributes to a failure in sustaining bodyweight after body weight loss. These circumstances require continuallystimulated thermogenesis. After losing weight for a short duration, anindividual's weight stabilizes. In order to maintain body weight thereis a need to control food intake, stimulate thermogenesis and increaseenergy levels on an ongoing basis.

Some undesired effects encountered by individuals desiring to lossweight include fatigue, low energy, and a lack of motivation and/ordepression.

Another undesired effect of increased accumulation of body fat is anincreased oxidative stress through the generation of reactive oxygenspecies and the downregulation of antioxidative enzymes. Thisdownregulation of antioxidative enzymes can contribute to thepathogenesis of diabetes, hypertension and atherosclerosis. Thus it isdesirable to provide an individual means to reduce stored body fat andsimultaneously offer protection from reactive oxygen species.

Increased oxidative stress due to increased body fat is thought to be anearly contributor to hypertension, coronary heart disease, type 2diabetes mellitus, stroke and even some forms of cancer and is thereforean attractive target strategy for combating the negative effects ofexcessive body fat while aiming to reduce the volume of stored body fatin an individual.

With the unprecedented rise in obesity throughout the world, thereexists both a need and want from individuals for improved aids, methodsand interventions directed to reducing body fat and maintaining loweredlevels of body fat, while also supplying beneficial antioxidantactivity.

While not necessarily obese, many individuals who are overweight canalso suffer from many similar conditions known to be associated withobesity including, among others, poor self-esteem and lowself-confidence, poor dietary and exercise habits, lack of energy andanxiety. Many of these individuals would benefit from the prevention orcorrection some of these conditions if they were able to prevent weightgain and/or maintain a normal body weight.

Therefore, there is a need to provide individuals compositions usefulfor increasing energy and promoting weight loss, for the treatment ofobesity, prevention of weight gain or maintenance of normal body weightand increasing energy.

SUMMARY OF THE INVENTION

The present invention provides for a dietary supplement that providesany one or more of the following benefits: help reduce and controlappetite; help control food cravings; help reduce hunger cravings; helpinduce feeling of fullness (satiety); promote and support weight loss;help reduce body mass index (BMI); help reduce waist and thighmeasurements; increase metabolism; increase thermogenesis; and increaseenergy.

In aspects, the present invention relates to methods and compositionsthat utilize plants and/or portions thereof containing chlorogenicacids.

According to another aspect of the invention, the dietary supplementfurther comprises at least one substance for increasing energy.

According to another aspect of the invention, the dietary supplementfurther comprises at least one thermogenic substance.

According to another aspect of the invention, the dietary supplementfurther comprises at least one satiety-promoting ingredient.

According to another aspect of the invention, the dietary supplementfurther comprises at least one antioxidant.

According to another aspect of the invention, the dietary supplementfurther comprises at least one prebiotic.

According to another aspect of the invention, the dietary supplementfurther comprises at least one probiotic.

According to another aspect of the invention, the dietary supplementfurther comprises at least one substance that decreases harmfulcholesterol.

According to an aspect of the invention, there is provided a dietarysupplement comprising Smallanthus sonchifolius and/or Phyllostachysedulis.

In aspects of the invention, extracts are obtained from the Smallanthussonchifolius and/or Phyllostachys edulis.

The compositions of the invention may further comprise variousSmallanthus sonchifolius and/or Phyllostachys edulis and extractsthereof, Smallanthus sonchifolius and/or Phyllostachys edulis combinedwith different amounts of biologically active small molecules or othertherapeutic agents. The compositions of the present invention areparticularly useful for promoting weight loss and/or the treatment ofobesity.

The present invention is further directed to a weight loss compositionuseful for treatment of obesity, comprising as an active component aneffective amount of at least one specific chlorogenic acid extractedfrom Smallanthus sonchifolius and/or Phyllostachys edulis and at leastone substance for increasing energy.

The present invention is further directed to a weight loss compositionuseful for treatment of obesity, comprising as an active component aneffective amount of at least one specific chlorogenic acid extractedfrom Smallanthus sonchifolius and/or Phyllostachys edulis, at least onesubstance for increasing energy and at least one antioxidant and/or atleast one thermogenic substance and methods of using same.

The present invention is further directed to a weight loss compositionuseful for treatment of obesity, comprising as an active component aneffective amount of at least one specific chlorogenic acid extractedfrom Smallanthus sonchifolius and/or Phyllostachys edulis, at least onesubstance for increasing energy, at least one antioxidant, at least onethermogenic substance and at least one prebiotic and/or probiotic andmethods of using same.

The present invention is further directed to the weight loss compositionfor promoting weight loss in an individual in need thereof.

The present invention is further directed to methods for promotingweight loss by administering the weight loss composition to anindividual in need thereof.

The present invention is further directed to the use of the weight losscomposition in the preparation of a medicament for promoting weight lossin an individual in need thereof.

The present invention is further directed to methods for promotingweight loss by administering the combination of raw plants andstandardized plant extracts in specific proportions.

Specific embodiments of the present invention are understood to comprisetubers and/or leaves of Smallanthus sonchifolius and/or Phyllostachysedulis; methods for preparing the same; and methods of preparing adietary supplement to aid in body fat loss, promote lipolysis whileaffording protection against reactive oxygen species resulting from theβ-oxidation of fats.

In another particular aspect of the present invention, there is provideda weight loss composition useful for treatment of obesity, comprising asan active component an effective amount of at least one specificchlorogenic acid extracted from Smallanthus sonchifolius and/orPhyllostachys edulis, and a physiologically acceptable carrier, at leastone substance for increasing energy and/or at least one antioxidant andmethods of using same.

In another embodiment of the present invention using Smallanthussonchifolius and/or Phyllostachys edulis extracts, Smallanthussonchifolius and/or Phyllostachys edulis extracts comprise about 1% toabout 99% by weight of the composition. In a preferred embodiment,Smallanthus sonchifolius and/or Phyllostachys edulis extracts compriseabout 10% to about 60% by weight of the composition. In a more preferredembodiment, Smallanthus sonchifolius and/or Phyllostachys edulisextracts comprise about 20% to about 50% by weight of the composition.

In an embodiment, the composition of the invention comprises Smallanthussonchifolius and/or Phyllostachys edulis extract present in an amount ofabout 35% to about 40% by weight at least one substance for increasingenergy and/or a thermogenic substance. Alternatively, the compositionsof the invention can be administered sequentially or simultaneously incombination with at least one substance for increasing energy and/or athermogenic substance.

In an embodiment, the composition of the invention comprises Smallanthussonchifolius and/or Phyllostachys edulis extract having at least 1%chlorogenic acids by weight.

In an embodiment, the composition of the invention comprises Smallanthussonchifolius and/or Phyllostachys edulis extract comprises about 20 to90% chlorogenic acids by weight and about 5 to 40% 5-caffeoylquinic acidby weight.

In an embodiment, the composition of the invention comprises Smallanthussonchifolius and/or Phyllostachys edulis extract comprises about 45%chlorogenic acids by weight and about 10% 5-caffeoylquinic acid byweight.

According to in an embodiment of the invention is a comestiblecomposition comprising an extract of Smallanthus sonchifolius and/orPhyllostachys edulis and at least one substance for increasing energywherein the extract of Smallanthus sonchifolius and/or Phyllostachysedulis comprises at least one specific chlorogenic acid, in an amount ofat least 5% by weight. And according to in an embodiment of theinvention the at least one specific chlorogenic acid is 5-caffeoylquinicacid.

In another aspect, the dietary supplement comprises phenolic acidsselected from the group consisting of caffeic, chlorogenic, rosamarinicand ferrulic. More preferably, the compositions include at least 5%chlorogenic acids by weight of the composition; preferably including atleast 10% chlorogenic acids by weight of the composition. Mostpreferably, the compositions are obtained from the extraction ofSmallanthus sonchifolius and/or Phyllostachys edulis parts with anaqueous organic solution mixture, in particular a water and ethanolsolution mixture, comprising small molecule compounds.

In another aspect, the dietary supplement comprises phenolic acidsselected from the group consisting of caffeic, chlorogenic, rosamarinicand ferrulic. More preferably, the compositions include at least 5%chlorogenic acids by weight of the composition; preferably including atleast 10% chlorogenic acids by weight of the composition. Mostpreferably, the compositions are obtained from the extraction ofSmallanthus sonchifolius and/or Phyllostachys edulis plant parts with anaqueous organic solution mixture, in particular a water and ethanolsolution mixture, comprising small molecule compounds.

In another aspect, the dietary supplement comprises about 100 to 700 mgSmallanthus sonchifolius and/or Phyllostachys edulis extract and about100 to 700 mg caffeine.

In another aspect, the dietary supplement comprises about 150 to 400 mgSmallanthus sonchifolius and/or Phyllostachys edulis extract.

In another aspect, the dietary supplement comprises about 200 to 400 mgSmallanthus sonchifolius and/or Phyllostachys edulis extract and about100 to 700 mg caffeine.

In another aspect, the dietary supplement comprises about 200 mgSmallanthus sonchifolius and/or Phyllostachys edulis extract and 200 mgcaffeine.

In another aspect, the dietary supplement comprises about 200 mgSmallanthus sonchifolius extract and/or Phyllostachys edulis extract(containing about 45% by weight chlorogenic acids and about 5% by weight5-caffeoylquinnic acid), about 200 mg of a substance for increasingenergy in a capsule or tablet.

The Smallanthus sonchifolius or Phyllostachys edulis extracts obtainedaccording to an aspect of the present invention have at least 1% byweight total phenolics, preferably at least 20% by weight totalphenolics, and most preferably at least 40% by weight total phenolics.

One aspect of the invention comprises a composition containing about 100to 700 mg Smallanthus sonchifolius or Phyllostachys edulis with 1-90% byweight chlorogenic acids.

One aspect of the invention comprises a composition comprising about 150to 400 mg Smallanthus sonchifolius or Phyllostachys edulis extractcontaining about 5% to 70% by weight chlorogenic acids and about 100 to700 mg caffeine.

In another aspect, the dietary supplement comprises about 200 mgSmallanthus sonchifolius or Phyllostachys edulis extract and about 100to 700 mg caffeine.

In another aspect, the dietary supplement comprises about 200 mgSmallanthus sonchifolius or Phyllostachys edulis extract and 200 mgcaffeine.

In another aspect, the extract of Smallanthus sonchifolius orPhyllostachys edulis comprises about 45 to 50% chlorogenic acids byweight and about 5 to 15% 5-caffeoylquinic acid by weight and thecaffeine contains about 10% to 100% by weight 1,3,7-trimethylxanthine.

In another aspect, the Smallanthus sonchifolius or Phyllostachys edulisextract contains about 45% by weight chlorogenic acids and about 5% byweight 5-caffeoylquinnic acid.

Specific embodiments of the present invention are understood to functionin the capacity of a dietary supplement to aid in body fat loss,lipolysis while affording protection against reactive oxygen speciesresulting from the β-oxidation of fats.

DETAILED DESCRIPTION OF THE EMBODIMENTS

As used herein, unless otherwise specified, the term “manage weightgain” includes, but is not limited to, treating, preventing or reducingweight gain, suppressing appetite.

As used herein, unless otherwise specified, the term “preventing,”includes, but is not limited to, inhibition or the averting of symptomsassociated with a particular disease or disorder.

As used herein, unless otherwise specified, the term “treating” refersto the administration of the composition after the onset of symptoms ofthe disease or disorder whereas “preventing” refers to theadministration prior to the onset of the symptoms, particularly topatients at risk of the disease or disorder.

As used herein, unless otherwise specified, the term “obese” includes,but is not limited to, a person having a Body Mass Index (BMI) ofgreater than or equal to about 26.

As used herein, unless otherwise specified, the term “average weight” or“of average weight” includes, but is not limited to, a person having aBody Mass Index (BMI) of less than about 26.

As used herein, the term “thermogenic” refers to an ingredient, whichincreases energy expenditure, also known as metabolic rate. It is theprocess of burning stored body fat. The certain thermogenic ingredientmay also have a property of inducing satiety.

The term “standardized” as used in the field of naturally derivednutritional products refers to the process for delivering a product witha specific minimum level of one or more plant constituents.Standardization represents the level of concentration of particularlydesired elements from a plant source. Methods for standardizing plantsubstances are well known in the art. Furthermore, the measurement ofparticular plant constituents on which standardization is based is alsowell known in the art.

The term “about” when used as a modifier of a numerical range or amountdesignates an approximation of the range or the amount whereby minordeviations from the range or amount are within the scope of theinvention. Such deviations are known in the art of manufacturingformulations having a number of different ingredients of varying weightand consistency.

The term “effective amount” shall be understood to mean an amount orquantity of the composition that is required to cause the metaboliceffects described herein. This amount is readily determined byobservation both before and after administration of the compositionsdescribed herein.

Unless specified otherwise, the term “% by weight” as used herein withreference to the standardized extract denotes the percent of the totalweight of the extract contributed by the active component. Thistheoretical value can differ from the experimental value, because inpractice, the extract typically may retain some of the water and/orother substances such as alcohols (e.g., ethanol) that may be used inpreparing the final product. In addition, the chemical composition ofthe plant material from a particular plant may vary with, for example,the conditions under which the plant is grown (e.g., soil or climate).

The term “% by weight of the composition” as used herein shall beunderstood to denote the percentage of the dietary ingredients in thecomposition useful for supplementing the diet of an individual.

A particular compound or mixture of compounds can exhibitpharmacological activity over a readily ascertainable range ofcompositions and dosages. Therefore it will be understood that thepercentages by weight recited throughout are meant to include suchvariations outside the stated percentages or percentage ranges as wouldbe expected by one skilled in the art.

As used herein, unless otherwise specified, the term “physiologicallyacceptable carrier,” includes, but is not limited to, a carrier mediumthat does not interfere with the effectiveness of the biologicalactivity of any active ingredients, is chemically inert, and is nottoxic to the consumer or patient to whom it is administered.

As used herein, unless otherwise specified, the term “pharmaceuticallyacceptable salts” refers to salts prepared from pharmaceuticallyacceptable non-toxic acids and bases, including inorganic and organicacids and bases.

It has now been shown that various raw botanicals and various extractsof raw botanical materials in the specific proportions reduce andcontrol appetite; help induce feeling of satiety; promote and supportweight loss; help reduce body mass index (BMI); help reduce waist andthigh measurements; increase metabolism; increase thermogenesis; andincrease energy.

Phenolic compounds, widely distributed in food plants, act as primaryantioxidants and thus may be beneficial for improving and/or preventinga number of chronic diseases. Phenolic compounds occur in nature asmixtures of esters, ethers, or free acids.

A major class of phenolic compounds are the hydroxycinnamic acids, whichare found in almost every existing plant. Caffeic, ferulic andp-coumaric acids are trans-cinnamic acids that occur naturally in theirfree forms or as a family of mono or diesters with (−)-quinic acid,collectively known as chlorogenic acids. Chlorogenic acids areantioxidant components produced by plants in response to environmentalstress conditions such as infections by microbial pathogens, mechanicalwounding, and excessive UV or visible light levels. The main classes ofchlorogenic acids found in nature are the caffeoylquinic acids,dicaffeoylquinic acids, and, less commonly, feruloylquinic acids, eachgroup with at least three isomers. The term “chlorogenic acid” comprises3-caffeoylquinic acid, 4-caffeoylquinic acid, 5-caffeoylquinic acid,3,4-dicaffeoylquinic acid, 3,5-dicaffeoylquinic acid,4,5-dicaffeoylquinic acid, 3-feruloylquinic acid, 4-feruloylquinic acid,5-feruloylquinic acid, 3-feruloyl-4-caffeoylquinic acid and otherstructural isomeric chlorogenic acids such as3-O-(3′-methylcaffeoyl)quinic acid, 5-O-caffeoyl-4-methylquinic acid and3-O-caffeoyl-1-methylquinic acid or mixtures thereof.

Phenolic compounds are known to be anti-tumor agents. Chlorogenic acidhas been shown to exert cancer preventive activities in animal models.Chlorogenic acid, an ester of caffeic acid and quinic acid, is anantioxidant in vitro and is suspected to be beneficial in preventingcardiovascular disease. Also, chlorogenic acid has shown to have achemopreventative effect on rat stomach cancer, and to inhibitmethylazoxymethanol induced large intestinal tumors in hamsters. Otherbeneficial properties such as hypoglycaemic, antiviral andhepatoprotective activities have been also attributed to chlorogenicacids in in vitro and in vivo and epidemiological studies.

Chlorogenic acid, the main phenolic acid in coffee, is able to protectthe gastric mucosa against irritations, and, therefore, improves thedigestibility of foods, beverages and medicaments. The improveddigestibility is expressed through a much reduced systemic acidsecretion (such as causes heartburn, etc.) which has been found to bedirectly dependent on an increased level of chlorogenic acid content inroasted coffee.

The chlorogenic acids of the present invention are not particularlylimited, and, for instance, those commercially available, or thoseprepared from various plants in accordance with known methods can beused. Organically synthesized chlorogenic acid can be used in additionto or in place of the botanical extract.

It is now believed that certain dietary polyphenolic compounds, inaddition to their antioxidant activities, may alter glucose metabolism.For instance, recent studies have linked heavy regular use of coffee todecreased risk for type 2 diabetes. The actions of caffeine seemunlikely to mediate this effect since it has been observed in those whouse decaffeinated coffee. Caffeic acid, the hydrolytic product ofchlorogenic acid, is known to have antidiabetic effects instreptozotocin-induced diabetic rats. Therefore, it is reasonable toexpect that chlorogenic acids and/or caffeic acid in coffee may beresponsible for these effects.

In vivo experiments studying the effects of chlorogenic acid have shownthat it is able to arrest the proliferation of 3T3-preadipocyte cells inthe G1 phase of development in a time- and dose-dependant manner. It isunderstood by the inventors that chlorogenic acid administration in vivowould translate into an inhibition of adipocytes differentiation andproliferation, resulting in a net reduction in adipose tissue.

Interestingly, in addition to the inhibitory effects of chlorogenic acidon preadipocyte proliferation, it has been suggested that chlorogenicacid decreases the intestinal rate of glucose absorption. Chlorogenicacid has also been shown to selectively inhibit hepaticglucose-6-phosphatase (G-6-P), the rate-limiting step in gluconeogenesisand decrease hepatic triglyceride levels in mice following 14 days ofadministration. Chlorogenic acid may also reduce glucose release fromthe liver which is often abnormally high in individuals with obesity,

It has been shown that about 33% of orally administered chlorogenic acidis absorbed in the small intestine of humans and it is understood by theinventors that chlorogenic acid not only inhibits adipose tissueproliferation but it also inhibits of glucose absorption.

Chlorogenic acids, ferulic acid in particular, are also known todirectly act on nitric oxide derived from the vascular endothelium. Itis believed that this will support flow mediated vasodilation anddelivery of nutrients via the systemic circulatory system.

According to an aspect of the present invention is the standardizationof the total phenolics, chlorogenic acids, and the entire plant extract.The standardized extracts have better batch-to-batch consistency. Theymay also have higher amounts of at least one specific chlorogenic acid.

There is also a need for plant extracts that have been standardized tothe presence of specific markers. Further there is a need for methods ofpreparing these extracts, as well as for compositions containing theseextracts. There is also a need for methods to promote weight loss and/orthe treatment of obesity and/or weight maintenance. According to anaspect of the present invention is the standardization of the totalphenolics, chlorogenic acids, and the entire extract. The standardizedextracts have better batch-to-batch consistency. They also have higheramounts of at least one specific chlorogenic acid. The inventiveextracts can be standardized according to at least one assay. Theextracts can be standardized by quantifying the concentration of totalphenolics. The extracts can also be standardized by quantifying theconcentration of specific chlorogenic acids.

The present invention further relates to an extract that has beenstandardized based on the concentration of individual specificchlorogenic acids. Specific chlorogenic acids may be assayed using HighPerformance Liquid Chromatography (“HPLC”). HPLC is known to thoseskilled in the art. Total phenolics can be assayed using theFolin-Ciocalteu (“FC”) method and is known to those skilled in the art.

The extraction process may be carried out using methods known in theart, including but not limited to solvent extraction, percolation, vatextraction, or countercurrent extraction. The degree of comminutation ofthe plant material prior to the extraction process should providesufficient particulate surface for the extraction solvent to contact thematerial. Extraction may be at ambient temperature or at elevatedtemperature. The resulting extract solution is then dried tosubstantially remove the solvent.

Chlorogenic acids may be extracted from the raw botanical materialaccording to any known methods. The present invention further relates toa method of preparing an extract from leaves which comprises: treating amass of plant material with a solvent suitable for extracting at leastone chlorogenic acid to yield an extract solution; concentrating theextract solution to an extent necessary to provide a minimum desirableconcentration of the active component for promoting weight loss, and;standardizing the extract to yield a known amount of at least onespecific chlorogenic acid.

The extraction process according the present invention may be carriedout using suitable solvents selected from water, and organic solventswith or without water. Suitable organic solvents include but are notlimited to non-toxic aqueous or non-aqueous monohydric or polyhydricalcohols, hexane, methylene glycol, glycerin, and similar solvents knownto those in the art. Other extraction methods such as use ofsuper-critical CO₂ may also be used. Preferably an aqueous solventhaving at least 10% volume/volume (“v/v”) of an alcohol is used in theextraction, more preferably at least 30% v/v of an alcohol, and mostpreferably at least 50% v/v of an alcohol. The preferred alcohols areethanol and methanol.

The concentration of total phenolics as well as certain specificphenolic markers is increased if the plant mass is freeze-dried afterharvesting and before extraction or processing. In an aspect of theinvention, the plant parts such as the bean, stems, leaves, or flowersare freeze-dried before extraction. Freeze-drying can be doneimmediately upon harvesting the plant. Or the harvested plant canimmediately be frozen and then freeze-dried within at least 30 days.

The extracts obtained according to an aspect of the present inventionhave at least 1% by weight total phenolics, preferably at least 20% byweight total phenolics, and most preferably at least 40% by weight totalphenolics.

Yacon (Smallanthus sanchifolius) is an Asteraceae from the Andean areasthat grows in zone of not more than 3,000 meters of altitude and theculture of which has expanded to other latitudes. In Peru it is foundespecially in humid temperate areas in Andean slopes, in dryinter-Andean valleys, as well as in the coast. Both the tubercle and theleaves improve lipid profile as well as intestinal absorption ofcalcium. The tuberous roots of yacon accumulate almost 10%, based on thefresh weight, of inulin type fructooligosaccharides (FOSs), which areknown as food ingredients with health benefits, the main saccharidebeing beta-1,2-oligofructane.

Phyllostachys, a genus of bamboo and more particularly, Phyllostachysedulis, is the largest of all temperate bamboos and produces edibleshoots. The leaves of bamboo have been used in Asian countries as a foodwrapping material to prevent food deterioration since ancient times. Theleaves have been used in the clinical treatment of hypertension,arteriosclerosis, cardiovascular disease, and certain forms of cancer.

In particular, the present invention relates to a standardized extractof Smallanthus sonchifolius or Phyllostachys edulis, which comprises atleast one specific cholorogenic acid, in an amount of at least 1% byweight based on the total weight of the extract. In a preferredembodiment the chlorogenic acid is in an amount of at least 5% by weightbased on the total weight of the extract. In a more preferredembodiment, in an amount of at least 10% by weight. In a most preferredembodiment of the present invention, the total phenolics are present inan amount of at least 20% by weight.

The present invention further relates to a method of preparing anextract from Smallanthus sonchifolius or Phyllostachys edulis. This massis subjected to an extraction process that is effective in concentratingat least one specific chlorogenic acid. The extract is then dried. Theextract is then standardized according to the invention. The extract canfurther be combined with fillers, excipients, binders and the like toform a composition suitable for administration for the treatment ofobesity.

In one specific method leaves of Smallanthus sonchifolius orPhyllostachys edulis are dried and comminuted and then extracted firstwith petroleum ether and next with hot water, until the extracts containno more chlorogenic acid. The combined extracts are concentrated andprecipitated with barium acetate. Then the filtrate is preciselyneutralized with sulphuric acid, the excess barium being removed at thesame time. The chlorogenic acid is separated from the neutral filtrateby means of lead acetate as a complex, which is washed with hot waterand to which hydrogen sulphide is then added after suspension in hotwater. After standing in a refrigerator for two to three days, thepotassium-caffeine-chlorogenate complex separates from the concentratedfiltrate. Caffeine is removed from the complex by chloroform and thenthe free chlorogenic acid is obtained by weak acidification.

In particular, in one embodiment of the invention, the extraction stepsare as follows: a) Smallanthus sonchifolius is harvested during theearly flowering season, when the amount of at least one specificphenolic marker is at its peak. b) The bean, stems, flowers, or leavesof the plant are immediately frozen to prevent fermentation, or areimmediately freeze-dried. The frozen plant mass is freeze dried withinone month of harvest. Freeze-drying is done at minimal heat. c) Thefreeze-dried material is pulverized to optimal particle size forpercolation extraction. d) The pulverized material is then extracted andsolid material is removed using the percolation method of extraction, inan ethanol/water solution wherein the ethanol is preferably 10% v/v,more preferably 30% v/v, and most preferably 50% v/v. e) The resultingextract is then dried and concentrated.

One aspect of the invention is a composition comprising Smallanthussonchifolius or Phyllostachys edulis with a substance for increasingenergy. In aspects, the substance for increasing energy is Lepidiummeyenii and/or Ptychopetalum olacoides. Lepidium meyenii (Brassicaceae),known as Maca or Peruvian ginseng, is a perennial crop of Peru. Forcenturies, the Andean Indians have utilized maca as a food and for itspharmacological properties; for example to enhance fertility. As a foodsource, maca displays a high nutritional value and is rich in sugars,protein, starches and minerals. It has a fleshy, edible, tuberous rootmacca that has been domesticated for at least 2000 years in the AndeanMountains at an altitude more than 10,000 feet. Dried maca root is richin amino acids, iodine, iron, and magnesium. Traditionally maca root hasbeen used in the Andean region for its supposed aphrodisiac and/orfertility-enhancing properties and energy-increasing properties. Anotherspecies is Lepidium peruvianum.

Muira puama (Ptychopetalum olacoides) is a remedy for sexual impotenceas wells as treating neuromuscular problems, rheumatism, influenza,cardiac and gastrointestinal asthenia and to prevent baldness. Muirapuama also significantly inhibits anti-cholinesterase activity in vitroin a dose- and time-dependent manner in rat frontal cortex, hippocampusand striatum suggesting improvement in facilitate memory retrieval.

An established component of obesity is abnormal fat metabolism,specifically, the breakdown of fat, or lipolysis. Body fat, stored astriglycerides in adipose tissue, is hydrolyzed to free fatty acids andglycerol through the process of lipolysis. In fat cells (adipocytes)lipolysis is controlled by adrenergic signaling and signaling throughadenosine receptors. Typically, stimulation of beta-adrenergic receptorsincreases lipolysis, whereas stimulation of adenosine A1 receptorsinhibits lipolysis. The specific effects of stimulation or inhibition ofeither adrenergic or adenosine receptors depends on the cell- ortissue-type involved and the precise panel of receptors expressed andthe downstream signaling connectivity.

Caffeine is a naturally occurring xanthine alkaloid found in some plantswhere it serves as a natural pesticide. In humans, however, it may havenumerous beneficial effects, the most common of which uses caffeine as asupplement to the central nervous system. In this capacity, it is usedas a stimulant and performance enhancer. Weight loss related to caffeinesupplementation has been observed in obese women and may be, at least inpart, due to increased lipolysis. Caffeine has additionally been shownto increase the basal metabolic rate.

While caffeine is structurally similar to adenosine, it binds to, butdoes not activate, adenosine receptors which are normally activated byadenosine to induce sleep. Thus, caffeine is a stimulant. Byantagonizing certain adenosine receptors, caffeine has the effect ofincreasing levels of intracellular cyclic AMP (cAMP), an importantsignaling molecule involved in many metabolic processes includingthermogenesis. Caffeine also increases cAMP levels by inhibitingphosphodiesterases which degrade cAMP. These actions of caffeine lead toan increase in the release of epinephrine and norepinephrine. Sinceepinephrine and norepinephrine use cAMP for signaling, increased levelsof cAMP will increase adrenergic signaling and thereby inducinglipolysis.

In aspects, the caffeine comprises 1,3,7-trimethylxanthine. In anotheraspect 1,3-dimethylxanthine or 3,7-dimethylxanthine can be substitutedfor 1,3,7-trimethylxanthine.

Cirsimarin is a flavonoid extracted from several plants includingMicrotea debilis (Phytolaccaceae), an herb native to South America,which is thought to be involved in various pharmacological activitieswithin the human body. Research suggests that cirsimarin may be alipolytic agent due to its antagonist effects on both adenosine A1 andA2 receptors and inhibitory effects on the enzyme phosphodiesterase.Phosphodiesterases are the main enzymes involved in the hydrolysis ofthe signaling molecule, cAMP, and have inhibitory effects on lipolysis.It is known that adenosine receptor activation acts to inhibitlipolysis. Therefore it will be understood that by inhibitingphosphodiesterase and inhibiting adenosine receptors, the inhibition oflipolysis is removed and fat burning is promoted. Use of cirsimarin iscontemplated because it stimulates lipolysis and promote weight loss byacting as a lipolytic agent due to its antagonism of adenosine receptorsand its inhibition of phosphodiesterase.

Antioxidants are of great interest because they may help to protect thebody against damage by reactive oxygen species (ROS). Studies have shownthat free radicals present in the human organism cause oxidative damageto different molecules, such as lipids, proteins and nucleic acids, andthus are involved in the initiation phase of some degenerativeillnesses. The ROS superoxide anion radical (O₂), hydrogen peroxide(H₂O₂), hypochlorous acid (HOCl) and hydroxyl radical (HO⁻) have beenimplicated in the pathophysiology of various disorders; thoseantioxidant compounds, which are capable of neutralizing free radicalsor ROS, may play a major role in the prevention of certain diseases,such as cancer, diabetes, cataracts, cerebral pathologies and rheumatoidarthritis.

Wolfberries, the common name for Lycium barbarum, also called Gojiberries are a nutritionally rich fruit originally grown in Europe andnow cultivated in China. Lycium barbarum contain all 8 essential aminoacids, as well as 21 trace minerals and a variety of vitamins. Intraditional Chinese medicine they have been used in for nearly 2,000years. In support of these traditional properties assigned to Lyciumbarbarum, recent studies indicate that extracts from Lycium barbarumfruit possess a range of biological activities, including effects onaging, neuroprotection, antifatigue/endurance, increased metabolism,glucose control in diabetics, glaucoma, antioxidant properties,immunomodulation, antitumor activity, and cytoprotection. Itsreddish-orange color is derived from a group of carotenoids, which makeup only 0.03-0.5% of the dried fruit. The predominant carotenoid iszeaxanthin, comprising about one-third to one-half of the totalcarotenoids.

Other chemical constituents found in Lycium barbarum fruit include smallmolecules such as betaine, cerebroside, beta-sitosterol, p-coumaricacid, and various vitamins. Other minor components include glutamine;asparagine; stigmasterol; cholest-7-enol; campesterol; cholestanol;24-methylene cholesterol; 28-isofucosterol;24-methylcholesta-5,24-dienol; 24-ethylcholesta-5,24-dienol;31-norcycloartanol; 31-norcycloartenol; cycloeucalenol; obtusifoliol;4a,14a,24-trimethylcholesta-8′24-dienol; 4a-methylcholest-8-enol;4-methylcholest-7-enol; 24-ethyllophenol; 4,24-methyllophenol;gramisterol; citrostadienol; 4a-methyl-24-ethylcholesta-7,24-dienol;lanost-8-enol; cycloartanol; lanosterol; b-amyrin; lupeol;24-methylenelanost-8-enol; 24-methylenecycloartanol; taurine and-aminobutanoic acid.

It is understood that the polysaccharide extracts which contain sixmonosaccharides (Ara, Rha, Xyl, Man, Gal, and Glc), galacturonic acid,and 18 amino acids, and share a Glycan-O-Ser glycopeptide structure,provides benefits such as enhancing the immune system function,improving eyesight, protecting the liver, boosting sperm production, andimproving circulation in an individual. The use of Lycium barbarumpolysaccharides in the treatment of age-related oxidative stress in micehas been shown to improve the total antioxidant capacity as well asimproved immune function. Furthermore, the same study also illustratedthat the antioxidant activity of the wolfberries could be increased withco-treatment of vitamin C.

Acerola (Malpighia emarginata) one of the richest sources of vitamin C(L-ascorbic acid) an is also known as Barbados cherry, West Indiancherry, Puerto Rican cherry, Antilles cherry, cereso, cereza, cerisier,and semeruco is a fruit which has been used to treat dysentery,diarrhea, and liver disorders. Other ethnobotanical uses include as anastringent and for fever. Acerola is also used for preventing heartdisease, “hardening of the arteries” (atherosclerosis), blood clots, andcancer.

Vitamin C, or L-ascorbic acid, is an essential nutrient required insmall amounts in order to allow a range of essential metabolic reactionsin animals and plants. Since the body does not make or store vitamin C,humans are required to ingest it in their daily diets. Ascorbic acid isa strong antioxidant and protects the body from oxidative stress, aswell as acting as a coenzyme in necessary enzymatic reactions. As astrong antioxidant and anti-inflammatory molecule, ascorbic acid hasbeen shown to protect against the common cold.

Cactus pear (Opuntia ficus-indica) fruit contains vitamin C andcharacteristic betalain pigments, the radical-scavenging properties andantioxidant activities. Consumption of cactus pear fruit positivelyaffects the body's redox balance, decreases oxidative damage to lipids,and improves antioxidant status in healthy humans. Supplementation withvitamin C at a comparable dosage enhances overall antioxidant defense.

Blueberries are a group of flowering plants in the genus Vaccinium. Thespecies are native to North America and eastern Asia and contain a highamount of anthocyanins, potent antioxidants.

Anthocyanins are the colorful flavonoids concentrated in brightlycolored berries and fruit (“anthos” means “flower” and “cyan” means“blue”) being most concentrated in bilberries, blueberries, cranberries,elderberries, purple grapes, red wine and hawthorn berries. Flavonoidshave been reported to demonstrate their benefits in lowering oxidativestress and also have beneficial effects on cardiovascular and chronicinflammatory diseases.

Anthocyanin extracts are important for the health of the micro-bloodvessel network and prevent blood platelet stickiness better thanaspirin. Anthocyanins bind to and stabilize collagen and elastin; theystabilize the phospholipids of endothelial cells and increase synthesisof collagen and mucopolysaccharides, which give the arterial wallsstructural integrity.

Anthocyanins also inhibit the proliferation of human cancer cell linesin vitro, an effect attributed to their antioxidant activity.Anthocyanins induce the secretion of insulin from rodent pancreaticβ-cells, the cells normally responsible for insulin secretion, which arethe cells compromised in diabetes. Ingested anthocyanins have been shownto be detectable in the plasma and brain as intact molecules 10 minutesafter ingestion by rats and to be excreted in the urine of both rats andhumans. Antioxidant supplementation can reduce the markers of cellulardamage. Therefore, supplemental with antioxidants should benefit anynutritional and exercise program.

Bilberries, Vaccinium myrtillus [Fam. Ericaceae], otherwise known asEuropean blueberries, huckleberry or whortleberry are rich inanthocyanins. Bilberry has traditionally been used in herbal medicine asan astringent to help relieve diarrhea. Bilberry anthocyanin extractsare beneficial for the cardiovascular system have strong antiplateletaggregating activity. Bilberry leaf constituents prevent the release andsynthesis of pro-inflammatory compounds such as histamine,prostaglandins, and leukotrienes and bilberry anthocyanins also supportthe lymphatic system and prevent bacteria from adhering to the bladderwall. Bilberry extracts also exert potent protective action on LDLparticles during copper-mediated oxidation.

Blueberries, Vaccinium corybosum and other and other blueberry speciesincluding Vaccinium alaskensis, Vaccinium membranaceum and Vacciniumovalifolium [Fam. Ericaceae], are also rich anthocyanins.

Carotenoids are isoprenic compounds that are naturally occurring inplants. There are over 600 known carotenoids split into two classes:xanthophylls and carotenes. The 6 major carotenoids are: alpha-carotene,beta-carotene, lycopene (carotenes); beta-cryptoxanthin, zeaxanthin andlutein (xanthophylls). Zeaxanthin is found in many vegetables andfruits, particularly green leafy vegetables such as kale and spinach.Zeaxanthin is widely known as a nutrient for protecting ocular function.It has long been thought that carotenoid intake also reduces the risk ofcertain forms of cardiovascular disease, stroke, and cancer. Zeaxanthinand its stereoisomer lutein, may prevent cellular damage in theseconditions by quenching singlet oxygen or neutralizing photosensitizers.

Açai berries (Euterpe oleracea) are a rich source of anthocyanin andpolyphenolic compounds, essential fatty acids, and vitamins.Cyanidin-3-glucoside is the main anthocyanin (1,040 mg/L of açai berryjuice), as well as 16 other polyphenolics at levels ranging from 4 to212 mg/L. Total anthocyanin content is 3.2 mg/g freeze-dried açai berrysamples on a dry weight basis where cyanidin-3-glucoside andcyanidin-3-rutinoside are the predominant anthocyanins. Resveratrol,albeit at very low levels, fatty acids, mainly oleic and palmitic acidscan also be found in açai berry. Plasma antioxidant capacity of 2.3- and3-fold is observed for açai juice and pulp after the consumption.

Gentian root and rhizome, Gentiana lutea L. [Fam. Gentianaceae],otherwise known as Bitter Root may have anti-inflammatory activity inaddition to antioxidant activities such as hydroxyl radical scavenging.

Schisandrin B is a dibenzocyclooctadiene compound that is isolated fromSchisandrae chinensis. Schisandrin has been used to enhance thedetoxification of xenobiotics in the liver and assist in liverregeneration. Recent studies have shown that schisandrin can protectvarious organs from free-radical induced damage.

Furthermore, it is known that oxidized low density lipoprotein (LDL) isa key factor in the initiation of atherosclerosis, one of thepathological processes involved in cardiovascular and cerebrovasculardisease. LDL expresses numerous adhesion molecules that appear toenhance the binding of monocytes to aortic endothelium, where they maybecome transformed into foam cells and initiate atherosclerosis.Research has shown that zeaxanthin can inhibit thickening of the wallsof carotid arteries and LDL-induced migration of monocytes to humanartery cell walls. It is believed that carotenoids for the ability toscavenge free radicals and inhibit lipid peroxidation in cardiovascularand cerebrovascular disease.

Phytosterols have cholesterol-lowering properties by reducingcholesterol absorption in intestines. The most abundant phytosterols(beta-sitosterol, campesterol, and stigmasterol) differ from cholesterolonly in the identity of one side chain or the presence of an extradouble bond. Cholesterol and phytosterol are very similar and the humanbody is not able to distinguish between them and therefore, phytosterolscompete with cholesterol for absorption in the small intestine. Anon-limiting list of phytosterols includes sitosterol, campesterol,sigmasterol, brassicasterol, sitostanol and campestanol.

Olive leaf comes from the olive tree (Olea europaea). Although olivesand olive oil are used as foods, olive leaf is primarily usedmedicinally or as a tea. Olive leaf helps to maintain a healthymetabolism as well as lowering cholesterol and blood pressure in peoplewith mild hypertension. According to an aspect of the invention, olivecorresponding to about 500 mg to about 1 g dried plant is used.Preferably, olive corresponding to 450 mg dried plant is used.

Alfalfa (Medicago sativa) [Fam. Leguminosae] may havecholesterol-lowering effects. Alfalfa is also extremely rich inantioxidants, including one powerful antioxidant called tricin, and is asource of chlorophyll and carotene.

Oat bran, Avena sativa L. [Fam. Gramineae], is rich in protein,approximately 30%, and contains all the essential amino acids along withchlorophyll, flavonoids, lecithin and enzymes. This abundance ofnutrients has made it popular for treating debility. It is alsoextremely rich in antioxidants, including polyphenols and one powerfulantioxidant called tricin. It also contains beta-glucan, which has beenshown to stimulate immune functions.

Angelica (Angelica archangelica) belongs to the family Umbelliferae.Angelica is said to be ‘ginseng’ for women and is recommended by many asa daily beauty tonic, to prevent hormonal imbalances and treat menstrualdifficulties (Amenorrhea) and is recommended for the prevention ofvascular disease. Angelica root is a source of bitters and aromaticsthat stimulate gastric and pancreatic secretion. Polysaccharide extractfrom the root Angelica has been studied for its liver protective effectin rodents and has been found to prevent liver toxicity caused byacetaminophen in mice without reducing the serum acetaminophenconcentration. It also normalized enzyme activities and levels includingalanine transferase (ALT), hepatic nitric oxide synthase (NOS) andglutathione in the liver.

Evening primrose oil [Gen. Oenothera] has been shown to decrease therisk of heart disease by lowering cholesterol and by decreasing the riskof blood clots (decreased platelet aggregation).

The flowers of calendula, Calendula officinalis [Fam. Asteraceae],contain high concentrations of colorful orange xanthophylls, carotenoidsand other flavonoids that are powerful antioxidants and the flavonoidextract has been shown scientifically to be effective againstinflammation, fever and to stimulate bile flow for aiding digestion andcleansing the liver.

Choline is a constituent of phosphatidylcholine (PC), which is acomponent of cell walls and membranes. It is involved in fat andcholesterol metabolism and transport. In this form, choline aids in fatmetabolism and transport away from the liver.

Ginseng (American ginseng, Asian ginseng, Chinese ginseng, Korean redginseng, Panax ginseng) appears to have antioxidant effects that maybenefit patients with heart disorders. Studies suggest that ginseng alsoreduces oxidation of low-density lipoprotein (LDL or “bad”) cholesteroland brain tissue. Several studies report that ginseng may boost theimmune system, improve the effectiveness of antibiotics in people withacute bronchitis, and enhance the body's response to flu vaccines.

Pomegranate (Punica granatum) delivers approximately 40% of an adult'sdaily vitamin C requirement and is high in polyphenolic compounds. Juiceof the pomegranate was effective in reducing heart disease risk factors,including LDL oxidation, macrophage oxidative status, and foam cellformation all of which are believed to be involved in atherosclerosisand cardiovascular disease. Consumption of pomegranate juice for twoweeks was shown to reduce systolic blood pressure by inhibiting serumangiotensin-converting enzyme (ACE).

Inosine (also known as hypoxanthine riboside, hypoxanthosine,2,3-diphosphoglycerate, 6-9 dihydro-9-B-D-ribofuranosyl-1H-purin-6-one,9-B-D-ribofuranosylhypoxanthine) and primarily used in the treatment forvarious forms of heart disease. Inosine monophosphate is a precursor foradenine, a nucleotide and purine base that reacts with ribose to formadenosine. Adenosine is a nucleoside that can be phosphorylated toproduce adenosine monophosphate (AMP), the diphosphate (ADP), thetriphosphate (ATP) and cyclic adenosine monophosphate (cAMP).

Gamma oryzanol is a mixture of ferulic acid esters of sterols andtriterpene alcohols extracted from rice bran oil and other grain oilssuch as corn and barley. Ferulic acid compounds also are present in manyfoods, including oats, berries, citrus fruits, tomatoes, olives, andvegetables. Gamma oryzanol is an important antioxidant within plantcells.

Turmeric (Curcuma longa), a perennial herb and member of theZingiberaceae (ginger) as is used as an anti-inflammatory and for thetreatment of flatulence, jaundice, menstrual difficulties, hematuria,hemorrhage and colic. The active constituents of turmeric are theflavonoid curcumin (diferuloylmethane) and various volatile oils,including tumerone, atlantone, and zingiberone. Other constituentsinclude sugars, proteins, and resins. There is about 0.3-5.4 percent ofcurcumin in raw turmeric. Water- and fat-soluble extracts of turmericand its curcumin component exhibit strong antioxidant activity,comparable to vitamins C and E. Turmeric has been found to have ahepatoprotective characteristic similar to silymarin. Turmeric'shepatoprotective effect is primarily due to its antioxidant properties,as well as its ability to decrease the formation of pro-inflammatorycytokines.

Turmeric's protective effects on the cardiovascular system includelowering cholesterol and triglyceride levels, decreasing susceptibilityof low density lipoprotein (LDL) to lipid peroxidation and inhibitingplatelet aggregation. Turmeric extract's effect on cholesterol levelsmay be due to decreased cholesterol uptake in the intestines andincreased conversion of cholesterol to bile acids in the liver.Inhibition of platelet aggregation by turmeric's constituents is thoughtto be via potentiation of prostacyclin synthesis and inhibition ofthromboxane synthesis.

Ficus carica has antioxidant properties and is used to treatconstipation, bronchitis, high cholesterol, eczema, psoriasis (chronicskin disease) and vitiligo (white skin patches).

Sunflower (Helianthus annuus) (Asteraceae) oil is rich in linoleic acid(omega-6), oleic acid (omega-9) and Vitamin E.

Bayberry (Myrica cerifera) (Myricaceae) stimulates lymphatic drainageand encourages the healing of mucus membranes. The primary chemicalconstituents of bayberry include essential oils, triterpenes (taraxerol,taraxaxerone, myricadol), flavonoids (myricitrin), phenols, starch,myrica wax (palmitic acid, stearic acid, myristic acid) lignin, albumin,gum, tannins and gallic acid. Bayberry is also been shown to alleviatearthritic pain.

Inulin (Cichorium intybus) is a type of naturally occurringfructose-containing oligosaccharide present in various fruits andvegetables such as onions, garlic, wheat, leeks, garlic, bananas,asparagus, and artichokes. Typically, inulin contains 2 to 150 fructoseunits which are linked by beta-(2-1) glycosidic bond with a terminalglucose. Inulin is resistant to digestion in the upper gastrointestinaltract and is fermented by the colonic bacteria, promoting intestinalbacteria and possibly acting as a mild laxative. In the colon, inulin ismetabolized into short-chain fatty acids-acetate, propionate, andbutyrate, lactic acids, and gases (e.g., hydrogen sulfide, carbondioxide, and methane). Inulin is also reported to possess anti-tumor,antimicrobial, hypolipidemic, hypoglycemic, and antiosteoporotic effectsand enhance mineral absorption and balance. Inulin from roots of chicoryand Jerusalem artichokes are marketed as nutritional supplements andfunctional foods. Nutritionally, it is considered a form of solublefibre. It is herein understood that inulin will act to benefit digestionby enhancing nutrient absorption, by promoting intestinal bacteria, andby mild laxative activity.

Inulin type fructooligosaccharides can be found in other plants.Smallanthus sonchifolius is also cultivated for its tubers, which areconsumed mainly as a “fruit”. In contrast with most edible roots,Smallanthus sonchifolius stores its carbohydrates in the form ofbeta-(2-1) fructooligosaccharides (FOS). FOS are sugars found naturallyin many types of plants but never in concentrations as high as inSmallanthus sonchifolius roots. FOS are able to resist the hydrolysis ofenzymes in the upper part of the human gastrointestinal tract. For thisreason, they have a low caloric value for humans.

Smallanthus sonchifolius FOS are completely fermented in the colon bybacteria that form part of the intestinal microflora. These bacteria(especially of the genus Bifidus and Lactobacillus) improve thegastrointestinal function. In this regard, FOS functions as a prebiotic.Prebiotics are an alternative for probiotics or their cofactors. Asnon-digestible or low-digestible food ingredients that benefit the hostorganism by selectively stimulating the growth or activity of one or alimited number of probiotic bacteria in the colon. This role is playedby fermentable carbohydrates, which are not digested or poorly digestedin the small intestine and stimulate, preferentially, the growth ofbifidobacteria and some Gram-positive bacteria, belonging to theprobiotic bacteria administered to humans.

Smallanthus sonchifolius tubers show an important effect by producing apositive balance of calcium and magnesium, and thus obtaining a greaterosseous mineral retention. FOS aid in digestion and prevent and controlconstipation. The sub-chronic use for 4 months of yacon root flour inmale rats was well tolerated and did not show adverse effects ortoxicity at a daily dose of 340 mg and 6800 mg FOS. Under theseconditions, the triglyceride levels decreased, although no effects onglycemia were observed. It does not appear that the hypoglycemic effectof yacon is due to a lower intestinal absorption of glucose.

In one specific method yacon tubers are frozen (−20° C.) immediatelyafter harvest. The frozen tubers are then cut into smaller parts andhomogenized in a homogenizer for 30 s. Ten grams of yacon tubers aretransferred into a 100 mL volumetric flask and filled with water. Theextraction mixtures is ultrasonicated for 15 min and filtered. Threemilliliters of the filtrates may be pipetted into 10 mL volumetricflasks and filled with methanol. Saccharide analysis of the tubers canbe performed using techniques familiar to those skilled in the art. Forexample, extracts of yacon tubers can be analyzed for sugar contentusing high-performance thin-layer chromatography (HPTLC).

According to an aspect of the present invention is a syrup compositionobtained from the tubers of Smallanthus sonchifolius. The syrup may beobtained from Smallanthus sonchifolius tubers according to methods knownto those skilled in the art. For example, harvested tubers which containabout 40 to 70% FOS, 5 to 15% sucrose, 5 to 15% fructose and less than5% glucose are juiced and filtered. The juice generally has an initialconcentration of sugars in the range from 8 to 13° Brix. Removal ofwater via evaporation and concentration can increase the concentrationto about 50 to 70° Brix.

In addition to prebiotics such as inulin and FOS, the use of probioticsis also contemplated. Probiotics are defined as selected, viablemicrobial dietary supplements beneficially affect the organism throughtheir effects in the intestinal tract. Some strains of Lactobacillus,Bifidobacterium and Saccharomyces, for example have been promoted infood products because of their reputed health benefits.

The physiological effects related to probiotic bacteria include thereduction of gut pH, production of some digestive enzymes and vitamins,production of antibacterial substances, e.g., organic acids,bacteriocins, hydrogen peroxide, restoration of normal intestinalmicroflora after diarrhea, antibiotic therapy and radiotherapy,reduction of cholesterol level in the blood, stimulation of immunefunctions, suppression of bacterial infections and removal ofcarcinogens.

Psyllium is a water-soluble fiber derived from the husks of ripe seedsfrom Plantago ovata. Psyllium is widely used as a fiber supplement forthe treatment of constipation. Psyllium husk is obtained by milling theseed of P. ovata to remove the hulls. Psyllium husk contains a highproportion of hemicellulose, composed of a xylan backbone linked witharabinose, rhamnose, and galacturonic acid units (arabinoxylans). Theseed consists of 35-percent soluble and 65-percent insolublepolysaccharides (cellulose, hemicellulose, and lignin). Psyllium isclassified as a mucilaginous fiber due to its powerful ability to form agel in water. This ability comes from its role as the endosperm of theP. ovata seed, where it functions to retain water in order to preventthe seed from drying out. Psyllium also has hypocholesterolemic effects,although the exact mechanism by which psyllium husk brings about areduction of cholesterol is not totally clear. Animal studies have shownpsyllium increases the activity of cholesterol 7 alpha-hydroxylase (therate-limiting enzyme in bile acid synthesis also referred to ascytochrome 7A [CYP7A]) more than twice that of cellulose or oat bran.Psyllium may also have an effect on appetite.

Caralluma is a cactus-like plant that grows abundantly in areas of Asia,the south Mediterranean, and parts of Africa. Caralluma is a cactus thathas historical use as an appetite suppressant during times of famine inIndia and Africa. In India, the plant is boiled and eaten whole butelsewhere only the green follicles are consumed. The name of the plantvaries between regions and in addition to caralluma, it is also knownas: Ranshabar, Maked shenguli, and Shindala makad.

Caralluma is reported to have anti-inflammatory, anti-nociceptive,anti-hyperglycemic, anti-ulcer, cytoprotective and appetite suppressantproperties. In addition to the anti-hyperglycemic and appetitesuppressant properties, caralluma or an extract thereof may have otheractivities conducive to maintaining or reducing weight such as theblocking the activity of the fat synthesis enzyme, citrate lyase. Thephytochemical constituents of caralluma include various glycosides(pregnane, flavone and megastigmane glycosides), bitter principles,saponins and various flavanoids.

There are a number of species of caralluma including but not limited to:C. fimbriata, C. indica, C. attenuata, C. tuberculata, C. edulis, C.adscendens, C. stalagmifera, C. umbellata, C. penicillata, C.russeliana, C. retrospiciens, C. arabica and C. lasiantha.

It is herein understood that inclusion of Caralluma or an extractthereof in a composition will support the maintenance or reduction ofbody weight in a subject by at least reducing appetite. It is furtherunderstood that Caralluma may further support the maintenance orreduction of body weight in a subject by antagonizing fat synthesis byblocking citrate lyase.

Cumin (Cuminum cyminum) is native from the eastern Mediterranean area toeastern India. It is used as a medicinal herb and in cooking throughoutthe Middle East, North Africa, South Asia, and parts of southern Europe.Evidence suggests that cumin may have antibacterial properties and hasbeen used as a diuretic (increases urine production), dyspeptic(relieves indigestion), carminative (prevents gas), stimulant,astringent and eases digestion. According to an aspect of the invention,cumin corresponding to about 500 mg to about 1 g dried plant is used.Preferably, cumin corresponding to 384 mg dried plant is used.

Lady's mantle (Alchemilla vulgaris) is a perennial herb found in Europe,North America, and Asia that has been used medicinally since the MiddleAges. It helps maintain body weight. According to an aspect of theinvention, lady's mantle corresponding to about 500 mg to about 1 gdried plant is used. Preferably, Lady's mantle corresponding to 690 mgdried plant is used.

Wild mint (Mentha longifolia) is known for the treatment of colic,menstrual disorders, indigestion, flatulence, pulmonary infection andcongestion, headache, fever, cough, colds and urinary tract infections.It also stimulates the flow of bile to the stomach and relaxes thedigestive tract muscles. According to an aspect of the invention, wildmint corresponding to about 500 mg to about 1 g dried plant is used.Preferably, wild mint corresponding to 324 mg dried plant is used.

A water extract of the common white kidney bean (Phaseolus vulgaris)inhibits digestive enzyme alpha-amylase in vitro. Alpha-amylase,secreted in saliva and by the pancreas, is responsible for breaking downstarch to simple sugars that are absorbed in the small intestine.Blocking this digestive enzyme may prevent the digestion of complexcarbohydrates, allowing them to pass through the digestive system. Theend result of blocking alpha-amylase would logically be a decrease inthe number of calories absorbed, potentially promoting weight loss.

Chromium, an essential trace mineral and cofactor to insulin, enhancesinsulin activity and has been the subject of studies assessing itseffects in carbohydrate, protein, and lipid metabolism. Reported effectsinclude an increase in lean body mass, a decrease in percentage bodyfat, and an increase in the basal metabolic rate. Chromium picolinate isan organic compound of trivalent chromium and picolinic acid, anaturally occurring derivative of tryptophan

Calcium carbonate is a colorless or white crystalline compound, CaCO₃,occurring naturally as chalk, limestone, marble, and other forms andused in a wide variety of manufactured products including dentifricesand medicines.

Although the present invention is not to be limited by any theoreticalexplanation, it is believed that increased calcium intake has asignificant effect on body weight and body fat. Studies show aconsistent effect of higher calcium intakes, expressed as lower body fatand/or body weight, and reduced weight gain at midlife. Specifically,calcium may assist in weight loss, weight management, regulation ofmetabolism, and the breakdown of fat. Studies show that increasingdietary calcium speeds up weight and fat loss. In a comparison trial,both the diets, either high in calcium or low in calcium, producedsignificant weight and fat loss. Weight and fat loss with respect to thehigh dairy diet were approximately 2-fold higher (p<0.01), and loss oflean body mass was markedly reduced (p<0.001) compared with the lowdairy diet. This study purports to show that employing calcium-richfoods in isocaloric diets reduced adiposity and improved metabolicprofiles in obese African Americans. Additionally, calcium carbonatefacilitates the prevention and treatment of calcium deficiencies, andthereby facilitates bone formations and maintenance.

Furthermore, it is known that that an isocaloric substitution of yogurt(diary) for other foods can significantly reduce central adiposityduring energy restriction and therefore augment fat loss. This waspurportedly shown by the use of control subjects (400-500 mg Ca/day), oryogurt diet (1100 mg Ca/day) with the dairy macronutritents controlledto the United States average values. After 12 weeks, fat loss wasmarkedly increased in the yogurt group, and mean tissue loss was alsoincreased in the yogurt group by 31%. Compared to the control group, an81% increase in trunk fat loss was also purported to be seen in theyogurt group, this resulted in decrease in waist diameter in yogurtgroup. It has been shown that calcium and dairy supplementationaccelerated fat and weight loss during a 24 week controlled study.Subjects on high-dairy diet (1200-1300 mg Ca/day) reportedly lost 70%more weight than those on the standard diet of 400-500 mg Ca/day andsubjects on the calcium enriched, but non-dairy diet lost on 26% moreweight than those on the standard diet. Therefore, this study purportsto show that calcium supplementation significantly increases weight lossand that calcium supplementation from diary sources exerts asubstantially greater effect of the weight and fat loss.

It is believed that a high calcium diet in the form of dairy products oras calcium carbonate may be useful in inducing the loss of adiposetissues via stimulating lipolysis, inhibiting lipogenesis, andincreasing the expression of uncoupling protein 2 in white adiposetissue.

Vitamin D is a steroid hormone, known to have an important role inregulating body levels of calcium and phosphorus, and in mineralizationof bone. Vitamin D is particularly important for the absorption ofcalcium from the stomach and for the functioning of calcium in the body.Thus, vitamin D is particularly important for strong bones and teeth.Vitamin D is also known as cholecalciferol, which is generated in theskin of animals when light energy is absorbed by a precursor molecule7-dehydrocholesterol. Cholecalciferol is used as a dietary supplement totreat and/or prevent low levels of vitamin D in the body. Although thepresent invention is not to be limited by any theoretical explanation,it is believed that vitamin D is highly involved in mineral metabolism,as well as bone growth and function. It has been shown that vitamin Deffectively facilitates intestinal absorption of calcium, and stimulatesabsorption of phosphate and magnesium ions. In the absence of vitamin D,dietary calcium may not be absorbed efficiently. Vitamin D stimulatesthe expression of a number of proteins involved in transporting calciumfrom the lumen of the intestine, across the epithelial cells and intoblood.

Vitamin B3 (Niacin) also known as or nicotinic acid is one of severalwater-soluble B-family vitamins. Niacin is often consumed as anutritional dietary supplement in the form of a multi-vitamin/mineralcomplex to improve general health. As a supplement in itself, niacin haslong been successfully used to improve blood lipid profiles. Xanthinolnicotinate is one of several forms of Niacin (vitamin B3) and isconsidered the most potent form of Niacin. Xanthinol nicotinate isclassified as a vasodilator. In patients with peripheral arterialobliterative disease, xanthinol nicotinate was found to haveanti-platelet and thrombolytic actions accompanied by an increase in therelease of NO. Xanthinol nicotinate may also have the effects ofenhancing cellular metabolism and increasing oxygen supply which may bethe mechanism of improvements in both short- and long-term memory.

Compositions of the present invention may be formulated foradministration to any suitable subject to promote weight loss. In apreferred embodiment, the subject is a mammal and even more preferably,the mammal is a human.

The administration may be by any conventional route such as oral,rectal, or nasal. Thus the composition may be a tablet, capsule,suspension, emulsion, solution, suppository or spray. The compositionsmay take the form of, for example, tablets or capsules prepared byconventional means with pharmaceutically acceptable excipients such asbinding agents (e.g., pregelatinized maize starch, polyvinyl pyrrolidoneor hydroxypropyl methylcellulose); fillers (e.g., lactose,microcrystalline cellulose or calcium hydrogen phosphate); lubricants(e.g., magnesium stearate, talc or silica); disintegrants (e.g., potatostarch or sodium starch glycolate); or wetting agents (e.g., sodiumlauryl sulphate). Non-limiting examples of binders include starch, andsugars such as sucrose, glucose and dextrose. Non-limiting examples ofdisintegrators include corn and potato starch, methylcellulose, agar,and bentonite. Non-limiting examples of coloring agents include any ofthe approved certified water-soluble FD&C dyes and mixtures of the same.

Tablets provided in accordance with the present invention may beuncoated or they may be coated by known techniques. In a preferredembodiment, the pharmaceutical composition may take the form of acapsule or powder to be dissolved in a liquid for oral consumption.Preparations for oral administration may be suitably formulated to givecontrolled release of the active compound.

Formulations for oral use include tablets or capsules which contain theactive ingredients mixed optionally with pharmaceutically acceptableinert excipients.

Such excipients include for example: inert diluents such as calciumcarbonate, sodium chloride, lactose, calcium phosphate, sodiumphosphate, dicalcium phosphate, calcium sulfate, mannitol, sorbitol, andthe like, etc.; granulating and disintegrating agents, for example,potato starch, alginic acid, etc.; binding agents, for example, starch,gelatin or acacia, etc.; and lubricating agents for example, magnesiumstearate, stearic acid or talc. Non-limiting examples of lubricantsinclude talc, starch, paraffin, stearic acid, magnesium stearate, andcalcium stearate.

Other pharmaceutically acceptable excipients include colorants,flavoring agents, plasticizers, humectants, etc. In certain embodiments,the active ingredient(s) may be delivered in a soft or hard gel capsuleby mixing the active ingredient with water or oil such as peanut oil, orolive oil and enclosing the resulting formulation in a capsule. Suitablecolorants include dyes that are generally suitable for food, drug andcosmetic applications, i.e., those known as F.D.&C. dyes.

The extracts of the present invention can be processed in the usual wayfor the preparation of the compositions, including but not limited totablets, controlled-release products, capsules, caplets, solutions, andthe like. The composition can also be formulated as confectionsincluding but not limited to gums, lozenges, troches and the like. Onepreferred composition is as a tablet containing between 50-300 mg of theextract or the raw plant material, and more preferably containing100-200 mg of the extract or the raw plant material.

The preparation may be in liquid form, for example, solutions, syrups orsuspensions, or may be presented as a powdered product forreconstitution with water, beverage or other suitable vehicle beforeuse. Such liquid preparations may be prepared by conventional means withpharmaceutically acceptable additives such as suspending agents (e.g.,sorbitol syrup, cellulose derivatives or hydrogenated edible fats);emulsifying agents (e.g., lecithin or acacia); non-aqueous vehicles(e.g., almond oil, oily esters, or fractionated vegetable oils); andpreservatives (e.g., methyl or propyl-p-hydroxybenzoates or sorbicacid).

The composition can be formulated to provide a homogenous mixture, orthe composition can be formulated so that the components arenon-homogenous.

The dosage may also be administered as an oral liquid dosage form bysuspending the active ingredients or extracts thereof in an aqueoussolution in admixture with a dispersing or wetting agent, suspendingagent and one or more preservatives. Suitable dispersing or wettingagents are, for example, naturally occurring phosphatides, for example,lecithin, or condensation products of ethylene oxide, fatty acids, longchain aliphatic acids, or a partial ester derived from fatty acids and ahexitol or hexitol anhydrides, for example, polyoxyethylene stearate,polyoxyethylene sorbitol monooleate, polyoxyethylene sorbitanmonooleate, etc. Suitable suspending agents are, for example, sodiumcarboxymethylcellulose, methylcellulose, sodium alginate, etc.

The solubility the acids in water can be improved by providing them inthe form of a pharmaceutically acceptable salt, and their physiologicaleffectiveness can be enhanced. Examples of a basic substance used forforming such a salt include inorganic bases such as alkali metal oralkaline earth metal hydroxides, for example, such as lithium hydroxide,sodium hydroxide, potassium hydroxide, magnesium hydroxide and calciumhydroxide; and ammonium hydroxide; and organic bases, such as basicamino acids such as arginine, lysine, histidine and ornithine; andmonoethanolamine, diethanolamine and triethanolamine, with the alkalimetal or alkaline earth metal hydroxides being particularly preferred.The agents according to the present invention may be formulated eitherby preparing such a salt and adding the salt to other components, or byseparately adding a salt-forming component and a component to be formedinto a salt to other components to react them in the formulation system.

For buccal administration, the compositions may take the form of tabletsor lozenges formulated in conventional manner. Lozenges will typicallybe shaped solids containing the extract in a candy or glycerinated base.

Alternatively, the active ingredients of the present invention may bedelivered over an extended time period by delaying disintegration andabsorption in the gastrointestinal tract to provide a sustained releaseeffect. A time delay material such as glyceral monostearate or glyceroldistearate may be employed for this purpose. Extended releaseformulations that may be employed to deliver the active ingredients ofthe invention are well known in the art.

If the composition is water-soluble, then it may be formulated in anappropriate buffer, for example, phosphate buffered saline or otherphysiologically compatible solutions. Alternatively, if the resultingcomposition has poor solubility in aqueous solvents, then it may beformulated with a non-ionic surfactant such as Tween or polyethyleneglycol. Thus, the compositions and their physiologically acceptablesolvates may be formulated for administration by inhalation orinsufflation (either through the mouth or the nose), oral, buccal,parenteral, or rectal administration.

For rectal applications, suitable formulations for compositionsaccording to the present invention include suppositories (emulsion orsuspension type), and rectal gelatin capsules (solution or suspensions).In a typical suppository formulation, the active ingredients arecombined with an appropriate pharmaceutically acceptable suppositorybase such as cocoa butter, esterified acids, glycerinated gelatin, andvarious water soluble or dispersable bases like polyethylene glycols andpolyoxyethylene glycols and polyoxyethylene sorbitan fatty acid esters.

The compositions may, if desired, be presented in a pack or dispenserdevice which may comprise one or more unit dosage forms comprising theactive ingredient. The pack may for example comprise metal or plasticfoil, such as a blister pack. The pack or dispenser device may beaccompanied by instructions for administration.

The composition can also be formulated as a confection such as a gum,lozenge, troche, and the like. Components that may be incorporated intoa confection include but are not limited to sweeteners, coloring agents,flavoring agents, preservatives, diluents, emulsifying agents,excipients, and the like.

Suitable sweeteners may be readily selected by those skilled in the art,and the amount of sweetener to be determined by taste. The sweetener maybe naturally occurring or synthetic, and may be nutritive ornon-nutritive. Examples of such sweeteners include, but are not limitedto, the saccharides, sugar alcohols such as alcohol and mannitol,water-soluble artificial sweeteners such as soluble saccharine salts,and dipeptide-based sweeteners such as L-aspartyl-L-phenylalanine methylester. Flavorings may include natural or artificial flavors such as mintoils, citrus oils, and the like.

The composition may be prepared as a gum using conventional means. The“gum base” may be one a number of types of compositions, typicallyprepared by heating and blending various ingredients, e.g., naturalgums, synthetic resins, waxes, and the like. Waxes, including naturaland synthetic waxes, petroleum waxes, paraffin waxes andmicrocrystalline waxes may also be incorporated into the gum base.

A preferred composition is a controlled-release formulation.Controlled-release formulations may employ alginates, microcrystallinecellulose, cellulose ethers, vegetable gums, and polymer complexes tosustain the extract in the system. Physical means such as coating,microencapsulation, and embedding in complex matrices may be employedfor this purpose. A preferred physical means is microencapsulation.

Other techniques known in the art can also be used to produce acontrolled release composition. The controlled release compositionyields an immediate release of effective dosage, and a sustained releasesuch as to yield an effective dosage duration ranging from 3-6 hours,preferably 3.5 to 4.5 hours.

In addition to the foregoing, compositions of the present inventioninclude formulations further comprising additional active ingredientsand/or inactive ingredients, including solvents, diluents, suspensionaids, thickening or emulsifying agents, sweeteners, flavorings,preservatives, solid binders, lubricants and the like, as suited to theparticular dosage form desired. Remington's Pharmaceutical Sciences,Sixteenth Edition, E. W. Martin (Mack Publishing Co., Easton, Pa., 1980)discloses various carriers used in formulating pharmaceuticallyacceptable compositions and which may also be suitable for use informulations of the present invention.

In accordance with an aspect of the present invention, the extract canbe included in the preparation of pharmaceutical compositions containinga sufficient concentration of the extract to achieve a desirablepharmaceutical effect within an acceptable dosage regimen. All thecompositions can be standardized for total phenolics, chlorogenic acidsand specific chlorogenic acids by varying the amount of standardizedextract added during the compounding process.

The present invention provides a method for promoting weight loss. Thecomposition may be provided 1 to 7 times daily in conjunction withproper diet and physical exercise. The exact dosage and dosage formswill vary according to the individual to be treated and will depend onsuch factors such as requirements of the individual, the severity of thedisorder or condition being treated and the age and health of the personbeing treated, as well as use of other medications and herbal remedies.The determination of optimum dosages can be made for a particularpatient by one skilled in the art. An example of an effective amount ofthe Smallanthus sonchifolius extract of the present invention is betweenabout 5 to 5000 mg, and especially between about 10 to 500 mg, a day peradult (weight: 60 kg).

The magnitude of the therapeutic dose of an active ingredient in theacute or chronic management of a disorder or condition will vary withthe severity of the disorder or condition to be treated and the route ofadministration. The dose, and perhaps the dose frequency, may varyaccording to age, body weight, response, and the past medical history ofthe consumer or patient. Suitable dosing regimens can be readilyselected by those skilled in the art with due consideration of suchfactors.

Except insofar as any conventional carrier medium is incompatible withthe ingredients of the invention, such as by producing any undesirableeffect or otherwise interacting in a deleterious manner with any otheringredient(s) of the formulation, its use is contemplated to be withinthe scope of this invention.

Examples Example 1 Example 1

It has now been shown that a dietary supplement prepared according tothe following specification in caplet form promote and support weightloss; help reduce body mass index (BMI); help reduce waist measurements;increase metabolism; increase thermogenesis and increase energy.

Dietary Ingredient Name Active % caffeine Smallanthus sonchifoliusextract, leaves  Chlorogenic acids 45  5-caffeoylquinic acid 10Phyllostachys edulis extract Lepidium meyenii

Example 2

A serving of the dietary supplement was prepared and comprises thefollowing ingredients in powder form.

Actives Dietary Ingredient Name % Anhydrous caffeine Smallanthussonchifolius extract  Chlorogenic acids 45  5-caffeoylquinic acid 10Goji Extract (Lycium barbarum)  std to polysaccaharides 3 AcerolaExtract (Malpighia glabra), fruit Zeaxanthin Blueberry Powder (Vaccinumcorymbosum), fruit Pomegranate powder (Punica granatum), fruit BilberryExtract (Vaccinium myrtillus), fruit Vitamin C 95%  std to Ascorbic Acid95 Vitamin D3 100,000 IU/g

Example 3

A serving of the dietary supplement was prepared and comprises thefollowing ingredients in powder form.

  Dietary Ingredient Name Psyllium powder (Plantago ovata), seedSmallanthus sonchifolius extract Oat Bran (Avena sativa) Inulin(Cichorium intybus), root

Example 4

A serving of the dietary supplement was prepared and comprises thefollowing ingredients in caplet form.

Active Stan. Dietary Ingredient Name (%) Smallanthus sonchifoliusextract,  Chlorogenic acids 45  5-caffeoylquinic acid 10 Goji extract(Lycium barbarum), fruit  Std to Polysaccharides 3 Acerola concentrate4-5:1 (Malpighia glabra), fruit  Supplying bioflavonoids Vitamin C -Ascorbic acid  Std to Ascorbic acid 95 Blueberry powder (Vacciniumcorymbosum), fruit  Supplying flavonoids Pomegranate powder (Punicagranatum), fruit & seed Bilberry extract 4:1 (Vaccinium myrtillus),fruit  Supplying Anthocyanins Zeaxanthin  Supplying Zeaxanthin 5 VitaminD3 (as cholecalciferol) beadlets - 1,000,000 IU

Example 5

A serving of the dietary supplement was prepared and comprises thefollowing ingredients in powder form.

Active Stan. Dietary Ingredient Name (%) Caffeine Anhydrous Smallanthussonchifolius extract inosine L-Histidine Muira PuamaPowder(Ptychopetalum Uncinatum/Olacoides), Bark Taurine L-glutamineL-ornithine hcl Gamma -Oryzanol Phytosterol Complex Total phytosterols90  Beta-sitosterol 40  Campesterol 20  Stigmasterol 14 Buffalo Herb(Medicago sativa) Mycozyme ( Fungal Amylase 1000 Units/Gram) DL-MalicAcid

Example 6

A serving of the dietary supplement was prepared and comprises thefollowing ingredients in caplet form.

Active Stan. Dietary Ingredient Name (%) Vitamin C - Ascorbic acid  Stdto Ascorbic acid Natural caffeine extract (Coffea 94 arabica) 50:1,bean/seed  Std to Caffeine 90 Smallanthus sonchifolius extract  Std toChlorogenic acid 45  Std to 5-coffeoylquinic acid 10  Std to Caffeine 2White kidney powder (Phaseolus vulgaris), bean/seed Acerola juice powder5:1 (Malpighia glabria), fruit Asian ginseng powder (Panax ginseng),root Opuntia ficus-indica powder, leaf Schizandra chinensis powder,fruit Turmeric powder (Curcuma longa), root Vitamin H  Biotin 1 Cholinebitartrate - encapsulated  Choline bitartrate 88 Goji extract 6:1(Lychium barbarum), fruit  Std to Polysaccharide 3 Pomegranate powder(Punica granatum), fruit & seed (whole fruit) Vitamin B3 - nicotinamideVitamin B6 - Pyridoxine HCl granular  Pyridoxine HCl 96  Pyridoxine 82Vitamin D3 (as cholecalciferol) beadlets - 1,000,000 IU Chromiumpicolinate (Chromax)  Chromium 12.18

Example 7

A serving of the dietary supplement was prepared and comprises thefollowing ingredients in capsule form.

Active Stan. Dietary Ingredient Name (%) Calcium carbonate  Calcium 39Natural caffeine dry concentrate extract (Coffea arabica), seed/bean Std to Caffeine 90 Smallanthus sonchifolius extract,  Chlorogenic acid45  5-caffeoylquinic acid 10  Caffeine 2 White kidney bean powder(Phaseolus vulgaris), bean Isoleucine Threonine Inositol Angelicaarchangelica powder, root Bayberry powder (Myrica cerifera), barkBilberry powder (Vaccinium myrtillus), fruit Gentiana lutea powder, rootNiacin (as nicotinic acid) Calendula officinalis powder, aerialparts/herb top Ficus carica powder, fruit Sunflower oil powder(Helianthus annuus), seed L-glutamic acid hydrochloride Evening primroseoil (Oenothera biennis), seed  Std to Gamma-linoleic 10 Folic acid Folic acid 10 Vitamin D3 - 1,000,000 IU/g (liquid) Chromium picolinate Chromium 12.68

Example 8

A comestible composition is prepared according to following proportions:198 mg of an extract of Smallanthus sonchifolius and 2 mg of vitamin C.

Example 9

A serving of the dietary supplement was prepared and comprisesSmallanthus sonchifolius, Lepidium meyenii and caffeine in syrup formproviding between 0.07 g and 0.21 g FOS/kg/day.

In the foregoing specification, the invention has been described withspecific embodiments thereof; however, it will be evident that variousmodifications and changes may be made thereto without departing from thebroader spirit and scope of the invention.

1-23. (canceled)
 24. A comestible composition, comprising an extract ofSmallanthus sonchifolius, at least one substance for increasing energyand at least one fibre.
 25. The composition of claim 24, wherein thefibre is water-soluble.
 26. The composition of claim 25, wherein thewater-soluble fibre is selected from the group consisting of Plantagoovata, Avena sativa, Cichorium intybus and mixture thereof.
 27. Thecomposition of claim 26, wherein the at least one substance forincreasing energy is Lepidium meyenii, Pytchopetalum olacides or amixture thereof.
 28. The composition of claim 24, further comprisingGentiana lutea or an extract thereof.
 29. The composition of claim 25,further comprising Gentiana lutea or an extract thereof.
 30. Thecomposition of claim 26, further comprising Gentiana lutea or an extractthereof.
 31. The composition of claim 27, further comprising Gentianalutea or an extract thereof.